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| Instrumentation Engineer - 01 post |
Apply here |
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| Role: |
| - Assists the Head – Clinical / Bioanalytical operations to provide GLP support on maintenance, calibration and validation of instruments. |
| Responsibilities: |
| - Electrical maintenance |
| - Monitoring and documenting the air conditioning and lighting status |
| - Ensure smooth functioning of the instruments by coordinate with supplier |
| - Maintenance of Instruments/equipments spare parts & inventory |
| - Maintenance of Eurotherm temperature recording system for freezers and cold room |
| - Ensure that cleanliness of Instruments and the surrounding |
| - Maintenance of centrifuges |
| - Labeling of all instruments and equipments |
| - Ensure appropriate entries in instrument/equipment logbooks |
| - Calibration of all instruments and equipments |
| - Updating SOPs for all instruments and equipments |
| - Ensuring Preventive maintenance of all instruments and maintaining the schedules |
| - Maintenance of calibration schedules |
| - Maintenance of IQ/OQ/PQ documents of all instruments |
| - Ensuring data backup for all the instruments |
| - Ensuring networking of all the computers and functioning of internet |
| - Testing (out source) and maintenance of record for Milli-Q water |
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| Senior Manager / General Manager - Clinical Trials - 01 post |
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| Role: |
| - Assists the CE-CRO by efficiently managing the clinical trial section and by providing technical know-how for the conduct of clinical trials at extramural sites. |
| Responsibilities: |
| - Ensure the conduct of clinical studies in accordance with FCRL SOPs and all applicable regulatory requirements |
| - Conduct feasibility assessments and accurate resourcing plans for new projects, considering existing resource requirements. |
| - Ensure that new clinical studies are implemented and completed to high quality standards within defined budgets and on time. |
| - Responsible for the operational management, administration, evaluation and delivery of projects, including appropriate allocation of internal or external resources (people, budgets, time), management of quality, communications, risk, documentation and study monitoring. |
| - Review, implement and authorize release of SOPs and provide requisite training to the staff. Also assess the training needs of the staff and organize relevant trainings. |
| - Liaise with the CE-CRO and other sectional heads for the efficient management of the CRO and to promote business development. |
| - Review and approve study documentation like protocol, ICDs, clinical study reports etc., as required. |
| - Ensure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. |
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| Report Writing Bio Analytical Section - 01 post |
Apply here |
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| Role: |
| - To compile all the clinical and analytical data for the timely preparation and release of study reports and method validation reports. |
| Responsibilities: |
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Maintenance of documents from various sections |
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Preparation and compilation of final reports with raw data sheets for submission |
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Preparation and review of expert report |
| - Review of method validation and analytical report and perform the outlier test in
the data |
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Checking the accuracy of report |
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To solve the regulatory queries |
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Keeping the documents updated for regulatory submission |
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To ensure that the reports meets the concerned regulatory requirements |
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| Report Writing Clinical Section - 01 Post |
Apply here |
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| Role : |
| - To compile all the clinical data for the timely preparation and release of study reports |
| Responsibilities: |
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Compilation of clinical reports with raw data sheets for submission |
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Keeping track of controlled and raw data forms |
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Checking the accuracy of report |
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Keeping the documents updated for regulatory submission |
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To ensure that the reports meets the concerned regulatory requirements |
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| Manager - Business Development - 01 post |
Apply here |
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| Role: |
| - To identify business contacts, prepare marketing material and requests for proposal. To assists Director - BD & Client Services in coordinating the day-to-day logistics. |
| Responsibilities: |
| - To develop marketing materials this will include website, brochures, banners/ back-drops and power-point presentations. |
| - To prepare the list of important domestic and international conferences and working toward the registration for short listed conferences. |
| - Coordinating with different vendors for stall arrangements and other logistics for participation in the conference. |
| - To prepare templates for preparing request for proposals for different services. |
| - To identify sales leads and contacts and to prepare proposals for submission to clients. |
| - Regular updates of the Pharma and CRO industry to the BD group. |
| Eligibility: The person should have around 2-5 years of experience in the CRO industry. |
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